BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM PEN NEEDLE

    MDR report key: 1883817 · Received October 22, 2010

    Report

    Report Number
    9616656-2010-00020
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED NEEDLE BROKE OFF OF PEN NEEDLE AND IT IS EMBEDDED ABOUT AN INCH AND HALF IN THE UPPER OUTER THIGH. CONSUMER WENT TO AN URGENT CARE FACILITY AND THEY DID AN X-RAY TO MAKE SURE IT WAS THERE AND IT DID SHOW UP. CONSUMER WENT TO AN EMERGENCY ROOM AND A DEEP INCISION WAS MADE, HOWEVER, THEY WERE NOT ABLE TO LOCATE THE NEEDLE. CONSUMER WAS ON ANTIBIOTICS FOR (10) DAYS IN CASE OF ANY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8MM PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R